Reported Mar 4, 2015 · Terminated

CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing…

Zimmer GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Gmbh · Sulzer Allee 8 · Winterthur, N/A · N/A

Is this the product you have?

  • CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
Lot codes and dates
  • Item numbers

    161 of 161 codes

    • 7210-22-000
    • 7210-22-350
    • 7210-22-800
    • 7210-26-000
    • 7210-26-035
    • 7210-26-350
    • 7210-26-800
    • 7210-28-000
    • 7210-28-004
    • 7210-28-400
    • 7210-28-800
    • 7210-32-000
    • 7210-32-004
    • 7210-32-400
    • 7210-32-800. Lot #'s: 61487412
    • 61516918
    • 61525215
    • 61533617
    • 61582735
    • 61417397
    • 61487413
    • 61417398
    • 61393996
    • 61393997
    • 61417401
    • 61417402
    • 61487414
    • 61487415
    • 61487416
    • 61487417
    • 61487418
    • 61487420
    • 61487422
    • 61487423
    • 61495211
    • 61495212
    • 61500247
    • 61516884
    • 61516885
    • 61516886
    • 61516888
    • 61525212
    • 61525213
    • 61533606
    • 61533607
    • 61533608
    • 61538022
    • 61538024
    • 61538026
    • 61554502
    • 61565073
    • 61565079
    • 61565081
    • 61565082
    • 61582736
    • 61417403
    • 61487424
    • 61487425
    • 61487426
    • 61495218
Amount recalled
6109

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 23, 2015 · Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.